Device for securing a cranial limb to the cranial top and for simultaneously closing craniotomy holes, and process for using it

ABSTRACT

A device ( 10 ) is described for securing a cranial limb to the cranial top ( 17 ) and for simultaneously closing craniotomy holes, comprising: a cortical support riser ( 12 ); first closing means ( 11 ) operatively connected to the cortical riser ( 12 ); second closing means ( 14 ) adapted to be secured to the cortical riser ( 12 ); and at least one handle ( 15 ) removably connected to the cortical riser ( 12 ) and adapted to drive the device ( 10 ) to take it from its rest position to its operating securing position. A process for using such device ( 10 ) is further described.

The present invention refers to a device, preferably made ofbiocompatible plastic elastic material, for securing a cranial limb andfor simultaneously closing holes obtained for performing the craniotomy.The present invention further refers to a process for using such device.

As known, the craniotomy, namely the incision and cutting of a bone limbof the cranial top, is the compulsory neuro-surgical procedure fortreating any intra-cranial lesion.

The bone limb is obtained by cutting one or more drill holes, accordingto two preferred procedures. The first one provides that a cutting bladeor a perforating device is used applied to the pneumatic drill, that,with free hands, from the key hole detaches the dura mater below andsimultaneously etches the bone. The second procedure, instead, providesthat the dura mater is dissected, with a curved periosteum-detachingdevice, from the bone between a drill hole and the other and afterwards,using a guide, by passing a saw wire, which, when pulled upwards at itsends with wide hands, etches the bone one segment at a time.

At the end of the neuro-surgical intervention, after having sutured thedura mater and suspended the edges to the bone, the limb is rested againinto the opening and is secured with detached metal or wire staples,passed through small drill holes paired on the free edge of the cranialbone.

It is however clear that a solution of this type generally does notallow an aesthetically acceptable closure, since it is not always ableto avoid that the bone limb can project, collapse, get slanted orrotate.

Object of the present invention, therefore, is solving the above priorart problems, by providing a device for securing a cranial limb to thecranial top that allows correctly ossifying the bone limb to the cranialtop edge and simultaneously closing the holes obtained for craniotomy.

Another object of the invention is providing a device that allows havinga lower tension on the brain, even if a brain edema occurs after anoperation.

In order to prevent such brain edema, a hole has been pre-arranged inthe upper part of the device, that can be easily opened with a dedicatedinstrument, to allow inserting a drainage.

These and other objects are obtained with a device for securing acranial limb to the cranial top and for simultaneously closing thecraniotomy holes as described in claim 1. Further features of theinvention are defined in the dependent claims.

Further objects and advantages of the present invention will be clearfrom the following description and the attached drawings, providedmerely as a non-limiting example, in which:

FIG. 1 shows a perspective view of a preferred embodiment of the devicefor securing a cranial limb to the cranial top and the simultaneousclosure of the craniotomy holes according to the present invention;

FIG. 2 shows a view of the device of FIG. 1 in a first step of its use;

FIG. 3 shows a view of the device of FIG. 1 in a second step of its use;

FIG. 4 shows a view of the device of FIG. 1 in a further step of itsuse; and

FIG. 5 shows a view of the device of FIG. 1 in the final step of itsuse.

With particular reference to the cited figures, the device for securinga cranial limb to the cranial top and for simultaneously closing thecraniotomy holes, according to the present invention is globallydesignated with reference number 10.

The device 10 has a lower ring 11, linked to the cortical riser 12 bytwo elastic arms 13 and an upper plate 14 (FIG. 4), which will have tobe inserted into the upper part of the cortical riser 12.

The cortical riser 12 will be equipped with a handle 15 and a ring 16for securing 16 that will be used for inserting the upper plate 14 (FIG.4).

The cortical riser 12, as connection between the lower ring 11 and theupper plate 14, due to the elasticity of the arms 13, allows using onlyfew sizes related to the bone thickness, for example three differentsizes, while the circular shape allows any rotation and even thenon-parallel positioning of the ring 11 with respect to the plate 14.

Finally, even. if it can be seen in all the Figures, in FIG. 5 a hole 22is expressly shown and better illustrated, which allows passing probesto suck liquids, for extravasations, drainages, etc., such hole 22 beinga further advantageous feature of the device 10 of the presentinvention.

Explaining in more detail the application modes of the cranial securingdevice 10 of the invention, it can be noted that the instrument operatorprepares the amount of devices adapted to secure the craniotomy in itsvarious sizes.

Such operations are performed by choosing the most suitable sizes forthe cranial top 17 thickness and the most suitable number of devices 10,depending on the craniotomy largeness and shape.

Moreover, if it will be necessary to insert a drainage, in one of thedevices the hole 22 pre-arranged in the securing ring 16 will have to beopened, through suitable drilling pliers (not shown).

The surgeon, with the already assembled catching pliers (not shown),inserts the lower ring 11 in the space between the cranial top 17 andthe dura mater 18, so that the cortical riser 12 is at the centre of thehole obtained in the cranial top 17.

The bone cover 19 is abutted onto the lower ring 11 of the device 10, asshown in FIG. 3.

Afterwards, the surgeon verifies the correct position of the cover 19and stretches, by means of the handle 15, the cortical riser 12 and theelastic arms 13 to be able to insert the upper plate 14 into thesecuring ring 16, like in FIG. 4. Finally, he removes the handle 15 witha scalpel (FIG. 5).

The cranial securing device 10 of the invention is advisable in allcraniotomy cases, since its shape and the different sizes in which itcan be made, according to the bone thickness, allow keeping the bonelimb stretched on board the cranial top, both on the internal and on theexternal margins, in order to allow the right ossification and to closethe holes obtained for the craniotomy.

At the same time, the elasticity of the used biocompatible plasticmaterial guarantees, after the operation, namely when brain edema, andtherefore brain swelling, conditions could occur, a lower tension on thebrain.

From the above description, the features of the device for securing acranial limb to the cranial top and for simultaneously closing thecraniotomy holes, object of the present invention, appear clear, as wellas its resulting advantages.

It is finally clear that numerous variations can be made to the devicefor securing a cranial limb to the cranial top and for simultaneouslyclosing the craniotomy holes, of the present invention, withoutdeparting from the novelty principles contained in the inventive idea.

Finally, when putting the invention into practice, materials, shape andsizes of shown details could be various, according to needs, and theycould be replaced with other technically equivalent details.

1. A device for securing a cranial limb to a cranial top and forsimultaneously closing craniotomy holes, the device comprising: at leastone cortical support riser; at least one lower closing ring operativelyconnected to the cortical riser, the lower closing ring being of anelastic type and being linked to the cortical riser by at least twoelastic arms; at least one upper plate adapted to be inserted in andsecured to the upper part of the cortical riser; and at least one handleremovably connected to the cortical riser and adapted to drive thedevice to an operating position for securing the cranial limb to thecranial top and for simultaneously closing the craniotomy hole to whichthe device is applied.
 2. The device of claim 1, wherein the corticalfurther comprises an upper ring connected to the handle and adapted toabut against the upper plate that is placed around the upper ring. 3.The device of claim 2, wherein the upper ring further comprises a holefor a passage of probes for sucking liquids, for extravasations, or fordrainage.
 4. A process for securing a cranial limb to the cranial topand for simultaneously closing craniotomy holes by using the device ofclaim 1, the process comprising the steps of: inserting the lowerclosing ring in a space between the cranial top and a dura mater, sothat the cortical riser is at a center of a hole obtained in the cranialtop; abutting a bone cover onto the lower closing ring of the device;verifying that the bone cover is correctly positioned; stretching thecortical riser through the handle above the cranial top to insert theupper plate abutting onto the cranial top and engaging the device tocomplete the securing of the bone cover to the cranial top; and removingthe handle.
 5. The process of claim 4, wherein the step of stretchingthe cortical riser comprises stretching the elastic arms to be able toinsert the upper plate into the securing ring. 6-7. (canceled)